(267 days)
Pruitt F3 Carotid Shunt K051067
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a temporary blood conduit, with no mention of AI or ML capabilities.
Yes
The device is described as a "temporary conduit" that allows "blood flow between the common and internal carotid arteries" during carotid endarterectomy. Its function as an artificial passage for blood flow to facilitate a surgical procedure aligns with the definition of a therapeutic device.
No
The device is a temporary conduit used in carotid endarterectomy to maintain blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, sterile, plastic conduit with balloons, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Pruitt F3-S Carotid Shunt is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Pruitt F3-S Carotid Shunt is described as a temporary conduit used during surgery (carotid endarterectomy) to maintain blood flow within the patient's body. It is a physical device inserted into blood vessels.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any specimens taken from the body. Its function is purely mechanical, facilitating blood flow during a surgical procedure.
Therefore, the Pruitt F3-S Carotid Shunt falls under the category of a surgical device or implantable device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pruitt F3-S Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
Product codes
MJN
Device Description
The Pruitt F3-S Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit.
The Pruitt F3-S Shunts are multi-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries.
The Pruitt F3-S Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
common and internal carotid arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been completed to evaluate the safety and performance of the Pruitt F3-S Carotid Shunt:
- Shunt lumen diameter
- Balloon diameter
- Balloon deflation time
- Balloon radial force
- Kink test
- Balloon inflation curve
The verification activities conducted indicate that Pruitt F3-S Carotid Shunt meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pruitt F3 Carotid Shunt K051067
Reference Device(s)
Vascushunt Carotid Shunt K861790
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
LeMaitre Vascular, Inc Xiang Zhang Director of Regulatory Affairs 63 Second Avenue Burlington, Massachusetts 01803
Re: K143454 Trade/Device Name: Pruitt F3-S Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: July 20, 2015 Received: July 27, 2015
Dear Xiang Zhang,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143454
Device Name Pruitt F3-S Carotid Shunt
Indications for Use (Describe)
The Pruitt F3-S Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K143454
510k Summary
Submitter's Information
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue, Burlington, MA 01803 |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Xiang (Vic) Zhang |
| Global Director of Regulatory Affairs | |
| LeMaitre Vascular, Inc. | |
| Email: xzhang@lemaitre.com | |
| Date Prepared: | August 26, 2015 |
| Device Name: | Pruitt F3-S Carotid Shunt |
| Trade Name: | Pruitt F3-S Carotid Shunt |
| Common Name: | Catheter, intravascular occluding, temporary |
| Regulation Number: | 21CFR §870.4450 |
| Classification Panel: | Cardiovascular |
| Class: | II (2) |
| Product Code: | MJN |
| Establishment | |
| Registration: | 1220948 |
| Establishment: | 63 Second Avenue |
| Burlington, MA 01803 | |
| Predicate Device: | Pruitt F3 Carotid Shunt K051067 |
| Reference Device: | Vascushunt Carotid Shunt K861790 |
| Device Description: | The Pruitt F3-S Carotid Shunt is designed to serve as an |
| artificial passage connecting two blood vessels, allowing | |
| blood flow from one vessel to another. This is | |
| accomplished by using a clear, plastic, sterile conduit that | |
| is held in place by a stabilization technique (balloons) on | |
| both ends of the conduit. |
The Pruitt F3-S Shunts are multi-lumen devices with
balloons on both the distal (internal carotid) and proximal
(common carotid) ends of the shunt. The balloons, when
inflated independently, act as a stabilization mechanism to |
| | maintain the position of the shunt when it is placed within
the common and internal carotid arteries. |
| | The Pruitt F3-S Carotid Shunt has features to aid the user
during shunt insertion and balloon inflation. The inflation
path of the proximal (common carotid) balloon is color-
coded. Sterile saline is injected from the blue stopcock,
through the blue lumen and into the blue common carotid
balloon. |
| Intended Use: | The Pruitt F3-S Carotid Shunt is indicated for use in carotid
endarterectomy as a temporary conduit to allow for blood
flow between the common and internal carotid arteries. |
| Summary of Technological
Characteristics: | Comparisons of the Pruitt F3-S Shunt with the predicate
Pruitt F3 Shunt show that technological characteristics such
as materials, biocompatibility, performance, sterilization,
and packaging of the proposed device are substantially
equivalent to the predicate device. The design modification
of the proposed device compared to that of the predicate
device are:
• Removal of the pressure relief balloon on the
internal inflation arm;
• Provide balloon diameter vs. inflation volume data
in the IFU to guide the users |
| Functional/Safety Testing: | The verification activities conducted indicate that Pruitt F3-
S Carotid Shunt meets the product performance
requirements of the device specifications and does not raise
any additional safety issues. |
| Sterilization: | The device is ethylene oxide (EO) sterilized according to
ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical
Devices - Validation and Routine Control of Ethylene
Oxide Sterilization" |
| Biocompatibility: | The materials used in Pruitt F3-S Carotid Shunt are
identical to those in the predicate device which has
established biocompatibility. |
| Summary of Product
Testing: | The following tests have been completed to evaluate the
safety and performance of the Pruitt F3-S Carotid Shunt:
• Shunt lumen diameter
• Balloon diameter
• Balloon deflation time
• Balloon radial force
• Kink test
• Balloon inflation curve |
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Summary of Pre-clinical N/A Study: Conclusion: LeMaitre Vascular has demonstrated that the Pruitt F3-S Carotid Shunt is substantially equivalent to the predicate devices based on its intended use and fundamental scientific technology.